Considerable advances have been made in the field of therapeutic agent (e.g. drug) delivery technology over the last three decades, resulting in many breakthroughs in clinical medicine. The creation of therapeutic agent delivery devices that are capable of delivering therapeutic agents in controlled ways is still a challenge. One of the major requirements for an implantable drug delivery device is controlled release of therapeutic agents, ranging from small drug molecules to larger biological molecules. It is particularly desirable to achieve a continuous passive drug release profile consistent with zero order kinetics whereby the concentration of drug in the bloodstream remains constant throughout an extended delivery period.
These devices have the potential to improve therapeutic efficacy, diminish potentially life-threatening side effects, improve patient compliance, minimize the intervention of healthcare personnel, reduce the duration of hospital stays, and decrease the diversion of regulated drugs to abusive uses.
A nano-scale device may be used in drug delivery products for the effective administration of drugs. In particular embodiments, the nano-scale device may be a nanochannel delivery device (NDD). In addition, nanochannel delivery devices can be used in other applications where controlled release of a substance over time is needed. Further, an NDD may be used as a filter within a fluidic pathway. In many embodiments a nano-scale device may have dimensional, structural, surface, or other properties required for proper function that must remain stable against micrometer or nanometer range modification for extended durations, e.g., months or even years.
In certain embodiments, a nano-scale device (including, e.g. an NDD) may be part of an apparatus that is implanted into a human or animal body, for example, to provide a therapeutic agent. In certain embodiments, the nano-scale device may be used to provide a controlled release of the therapeutic agent from the implanted apparatus. Both the therapeutic agent and the body, however, contain fluids and chemical compounds that may attack over time certain materials used in the construction of an nano-scale device, which can affect the structural stability of the nano-scale device and/or the ability of the nano-scale device to control the release of the therapeutic agent. The materials in the nano-scale device “fluid path” (e.g., the path that a therapeutic molecule travels passing through the nano-scale device) and any and all other surfaces of the nano-scale device that might be exposed to bodily fluids, therapeutic agents, or other potentially deleterious environmental factors, should therefore be resistant to any and all degradation in form and function from those fluids, agents, and factors.